Cleaning validation specialist

Job Title:

Validation Specialist in a Pharmaceutical Organization


Duties:

* Develop and adhere to validation strategies, coordinating with outside vendors, writing protocols independently, submitting samples, analyzing test results, and preparing technical reports.
* Execute routine business activities such as equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments.
* Provide support during commissioning phase by reviewing and approving documents ensuring documentation complies with standards.
* Participate in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT.
* Write technical reports, perform statistical analysis of data.
* Adhere to the latest regulatory guidelines.
* Represent the IPT on cross-functional project teams.
* Provide technical input and support and present as an SME on relevant topics during regulatory inspections.
* Ensure adherence to highest standards for Compliance (Quality and Safety).
* Ensure compliance with site EHS policy cGMP and other business regulations and support Technical IPT input to risk assessments audits regulatory inspections and incident investigations.
* Participate and comply with Manufacturing Division Quality Management System (QMS) requirements including ownership as relevant.


Education and Experience:

* Experience as a validation specialist in a pharmaceutical or highly regulated environment and a B.Sc. Degree or other qualification in Chemical Engineering Biochemistry Microbiology Chemistry or a related field.
* Experience in at least three of the following areas C&Q validation Cleaning Validation Equipment validation Process operations or manufacturing Process Engineering.
* A working knowledge of GxP systems associated with this role would be advantageous these include but are not limited to GLIMS and eVAL electronic batch records.